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Evaluation of the Efficacy of the Live Attenuated Tetravalent Dengue Vaccine Against DENV-2 and DENV-3 Challenge

NCT03416036 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 64

Last updated 2020-01-18

No results posted yet for this study

Summary

The purpose of this study is to evaluate the ability of a single dose of a live attenuated recombinant tetravalent dengue vaccine (TetraVax-DV-TV003, referred to as TV003) to protect against infection with a controlled human infection strain of either DENV-2 (rDEN2Δ30-7169) or DENV-3 (rDEN3Δ30) in adults 18 to 50 years of age with no history of previous flavivirus infection.

Conditions

  • Dengue

Interventions

BIOLOGICAL

TetraVax-DV-TV003 (TV003)

TV003 contains 10\^3.3 plaque-forming units (PFU)/mL of rDEN1Δ30, 10\^3.3 PFU/mL of rDEN2/4Δ30(ME), 10\^3.3 PFU/mL of rDEN3Δ30/31-7164, and 10\^3.3 PFU/mL of rDEN4Δ30. Administered by subcutaneous injection in the deltoid region of the upper arm

BIOLOGICAL

rDEN2Δ30-7169 (DENV-2)

Administered at a dose of 10\^3 PFU by subcutaneous injection in the deltoid region of the upper arm

BIOLOGICAL

rDEN3Δ30 (DENV-3)

Administered at a dose of 10\^3 PFU by subcutaneous injection in the deltoid region of the upper arm

BIOLOGICAL

Placebo

Administered by subcutaneous injection in the deltoid region of the upper arm

Sponsors & Collaborators

  • National Institute of Allergy and Infectious Diseases (NIAID)

    lead NIH

Principal Investigators

  • Anna Durbin, MD · Johns Hopkins Bloomberg School of Public Health

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-11-28
Primary Completion
2019-01-17
Completion
2019-06-04
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03416036 on ClinicalTrials.gov